Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Korea Cancer Center Hospital

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: Stereotactic body radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01850667

K-1201-001-004 (Other Identifier)

KCT0000454 (Registry Identifier)

Details and patient eligibility

About

The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence. Recently several small studies reported high tumor response and local control rate after stereotactic body radiotherapy (SBRT) alone or with TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable HCC after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall response rate of 73% and 2-year local control rate of 95%. They reported severe gastrointestinal toxicity of 11% because there was no normal tissue constraint for gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest levels possible. In addition, they found that the presence of gastroduodenal ulcer before SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study, we will conduct a multicenter phase II trial on maintenance of treatment results and reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of gastrointestinal tract according to gastroduodenal ulcer.

Enrollment

74 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients ≥ 20 years of age
Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
Unresectable HCC
Inaccessible to local ablative treatment
Cirrhotic status of Child Pugh class A or B7
Eastern Cooperative Oncology Group performance status 0 or 1
Tumor size < 10cm
The volume of uninvolved must be at least 700 ml
Incomplete response after trans-arterial chemo-embolization of 1-5
A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of SBRT
No evidence of an uncontrolled lesion at any other site
No evidence of complications of liver cirrhosis
No evidence of uncontrolled inter-current illness
Patient or guardian must be able to provide verbal and written informed consent